International Journal of Research and Review

www.ijrrjournal.com E-ISSN: 2349-9788; P-ISSN: 2454-2237

Review Article

Quality Added Life Years: A Tool for Biologics and Biosimilars Marketing
Manish Adhia, Bhavya Bhasin, Sonali Sakhrale

SVKM’s NMIMS, Shobhaben Pratapbhai Patel School of Pharmacy Technology and Management,
Mumbai-400056
Corresponding Author: Manish Adhia

ABSTRACT

Definition of quality of life has been much debated about, and continues to be blurred. The four
approaches which have been identified for their contribution in measuring and evaluating the health
level in a given population are epidemiological or biomedical approach, functional/dysfunctional
approach, cultural approach and economic approach. The health-related quality of life, is a value
which is assigned to duration of life modified by impairments, functional states, perceptions and
social opportunities that are influenced by disease, injury, treatment or policy. Biologics and
biosimilars are a class of medications which do not tend to follow the norms of the economics of
small molecules and chemical drugs. Bevacizumab is used for metastatic colorectal cancer (mCRC),
and the chemotherapy regimens for this cancer have been well established. Bevacizumab has high
acquisition costs and its economic value has been questioned in recent pharmacoeconomic studies. In
the case of diabetes, QALY is derived from utilities and these are important in terms of decisions
regarding reimbursement policies, insurance policies and cost-effectiveness. In addition to concerns
regarding costs associated with cancer and diabetes, targeted immunomodulators and other drugs
associated with treatment are also a concern because of rising prices in recent years. QALY can be a
tool that can help marketers add more value to their marketing strategies and communications in these
therapy areas.

Key words: quality of life, biologics, biosimilars, medications, marketing.

INTRODUCTION economists. The four approaches which

Definition of quality of life has been
much debated about, and continues to be
blurred. However, the definition of health
coined by WHO in the year 1958, throws
light on the definition of quality of life as
“Physical, mental and the social well-being
and not merely the absence of disease and
infirmity.” This definition was criticised due
to the unmeasurable concept that it is, which
eventually led the quality of life researchers
to devise methods of measuring health in all
the three dimensions of physical, mental and
the social well-being. For the measurement
of health status, various techniques have
been applied by sociologists, psychologists,
statisticians, epidemiologists and
have been identified for their contribution in
measuring and evaluating the health level in
a given population are epidemiological or
biomedical approach,
functional/dysfunctional approach, cultural
approach and economic approach.
The epidemiological or biomedical
approach defines health as a biological
phenomenon. It involves classification of
diseases into categories depending on the
symptoms of each disease and considers
factors like the hospital discharges as units
of medical system output.
The functional/dysfunctional
approach is normally considered as an
extension of the biomedical approach as it

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 Manish Adhia et.al. Quality Added Life Years: A Tool for Biologics and Biosimilars Marketing
focuses on measuring the impact of
biological conditions or dysfunctional states
of health. (e.g.: inability to walk, dress etc).
The cultural approach is a further
extension of the first two approaches and
associates the above described conditions
with the “stigma” that the society generally
associates with “deviant” behaviour. This
approach adds a new dimension to the
definition of illness considering how the
society perceives a person to be ill or not
regardless of the biomedical and
dysfunctional acknowledgement. (e.g.
Inability to socially move around in the
society)
The economic approach considers
the measurement of health status by
considering the concept of utility. The
concept of utility encompasses ethical
beliefs, norms and value judgements
concerning the identification and assessment
of medical needs. [1]
The health-related quality of life, is a
value which is assigned to duration of life
modified by impairments, functional states,
perceptions and social opportunities that are
influenced by disease, injury, treatment or
policy. The concept of measuring health
related concept of life started in the 1970s
with researchers putting forward various
platforms like questionnaires and indexes
for measuring the health-related quality of
life in different diseases like Alzheimer’s,
Asthma, Arthritis, Cancer and Diabetes. The
instruments used to measure the ability of
people to function in their everyday life
were essentially categorised as follows:
Generic instruments
These are designed to measure the
health status of a given population across
different socio-economic conditions and are
applicable across a wide range of disease
conditions. Examples of such generic
instruments include Sickness Impact profile
and Nottingham Heath Profile.
Disease specific instruments
These are designed to assess the
health status of a specific population groups,
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Vol.5; Issue: 11; November 2018
or people in specific diagnostic categories.
These instruments are capable of assessing
the changes in health conditions with
respect to the different stages of a specific
disease. Examples of such instruments
include Asthma Quality of Life
Questionnaire, and Inflammatory Bowel
Disease Questionnaire directed at Asthma
and Inflammatory Bowel Disease
respectively. [2]
Quality added life years (QALY)
QALY is an utility measurement, which
captures both the quality and quantity of
life. Life expectancy is the most widely
accepted form of estimating the quantity of
life. The Quality of life is more difficult to
measure as it embraces a larger spectrum of
health dimensions dealing with the physical,
emotional and social aspects of well being.
The mathematical expression of QALY is as
follows:
U {Q, L} = a L’ U(Q)…………….(1)
Where,
a: constant
r: a parameter which measures the
individual’s attitude to risk (risk lover, risk
neutral, risk averter)
U(Q): describes the quality of health or
quality of a given level of health status
adjusted over a range of values from 0 to
100. 0 expresses worst possible level of
health while 100 expresses best imaginable
level of health.
The main objective of QALYs is to
calculate an algorithm for assessing the
relative benefits of alternative treatments.
Usually, allocation of limited health care
resources is done on the basis of QALY by
analysing out of the patient pool, which
patient will be maximum benefitted by the
treatment as understood by QALY. [1] At the
individual level, this is generally expressed
as maximum QALYs per unit of cost.
QALYs are then further used for calculation
for Cost Utility ratio using the expression
number 2.
……………..(2)
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Where, A and B are two therapies in
comparison for a particular disease. [3]
Biologics and biosimilars are a class of
medications which do not tend to follow the
norms of the economics of small molecules
and chemical drugs. While the difference in
cost of a small molecule innovator and
generic is almost as much as 80% of the
price associated with the innovator, it does
not stand true for biologics and biosimilars.
[4]
Biosimilars are similar to the innovator
biologic and not exactly the same due to the
complex structure of proteins and biologic
molecules. This complexity makes the
process of manufacture of a biosimilar as
expensive as a biologic which makes
playing the price game difficult. This paper
explores the possibility of use of QALY as a
tool to justify the value proposition of a
biosimilar which can rationalise the costs
associated with the therapy with particular
attention to three diseases namely, cancer,
diabetes and rheumatoid arthritis. [5]
QALY for biologics and biosimilars in
cancer
Affordability of premium priced
biologics and biosimilars has been a matter
of concern since their introduction. It is
estimated that only 0.05% of the entire
population of India can afford the high
priced biologics and biosimilars. Owing to
the complexity of the molecule, the
preparation of biosimilars is equally
resource investing as a biologic which
doesn’t provide a significant price margin to
play. Essentially, this ends up in biosimilars
being priced at a minimum of 80% of the
price of the innovator biologic. Adding to
this, almost one third of the Indian
pharmaceutical industry is under price
control. Given their high price, cancer drugs
are likely to be affected by such policies in
the future. This acts as a big deterrent for
the multinationals who wish to introduce
highly effective biologics and biosimilars in
the Indian market. To address such issues,
new drug pricing strategies are needed to
ensure the commercial viability of highly
innovative therapies. [6]
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Vol.5; Issue: 11; November 2018
Value based pricing and outcome-
based pricing are examples of strategy
which can help justify the price of a
innovative therapy in terms of the value and
outcome that it provides to the life of the
patient. Value based pricing when combined
with pharmacoeconomic modelling
techniques like QALY can help in
determining the costs and consequences of
new therapies relative to the standard care.
However, one problem associated with the
use of QALY is setting the threshold value
of the country. WHO has provided a
solution by adjusting such parameters with
the country’s GDP to establish the
thresholds of economic value. This acts as a
guide for foreign MNCs wanting to launch
innovative therapies in India as the price set
would be in harmony with the purchasing
power parity of the population. This would
ultimately lead to wealthier nations paying
more for the therapies while the developing
ones pay a comparatively lesser amount. [6]
George Dranitaris et al in their work have
proven the successful use of parameters like
QALY for the value-based pricing of
bevacizumab for improved patient access. [7]
Bevacizumab is used for metastatic
colorectal cancer (mCRC), and the
chemotherapy regimens for this cancer have
been well established. Bevacizumab has
high acquisition costs and its economic
value has been questioned in recent
pharmacoeconomic studies. Clinical studies
have proven irinotecan and oxaliplatin to be
the first and second line of treatment for
mCRC. In addition to this, the protocol also
established the need to introduce a anti-
vascular endothelial growth factor (VEGF)
like bevacizumab at some point of time.
Though all the three molecules are available
in India, their accessibility is limited due to
their high price. The Canadian guidelines
for economic evaluations and the panel on
cost effectiveness in health and medicine of
the United States suggested that the
treatment preferences should be measured
using a population of general public who
will be potential future patients. Keeping
this in mind, their study was directed
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 Manish Adhia et.al. Quality Added Life Years: A Tool for Biologics and Biosimilars Marketing
towards the general public. It has also been
proven in previous economic study that a
patient surrogate group consisting of nurses
is most simulating with the patient
population and doesn’t affect the findings of
the cost-utility studies. In their interviews
with the participants, bevacizumab was
addressed as “new drug”. The respondents
were then asked how many months of
“optimal health” they considered being
equivalent to the time spent in each of the
less than optimal health states described in
the model. These measures were then used
to weigh each branch of the model by the
quality of life experienced by a patient
living through that time period.
The clinical, economic and interview
data was all then combined to calculate the
cost utility ratio with the primary objective
of estimating a suitable price per dose of
bevacizumab. The target benchmark used
was a price of US$9300 per QALY gained
which is three times the Indian per capita
GDP. The base case analysis suggested a
price of US$98 per QALY gained which
also takes into account the per capita
income of the population of the country.
The price of the drug is likely to reach $253
per month if the survival benefit is to reach
6 months. Most new medicines have not
been able to provide a survival benefit of
more than 3 months. The amount of QALY
added by bevacizumab becomes a value
proposition justifying the pricing of the
drug. [7]
The survival benefit of extra 3
months demonstrated by bevacizumab
becomes a point of differentiation of major
companies having bevacizumab in the
product portfolio. QALY can aid in proving
the value provided by a biosimilar in terms
of the outcomes produced. The latest
development in anti-cancer therapy is the
CAR-T cell therapy being investigated for
launch by Novartis in India. QALY as a
parameter has the potential of convincing
the physicians, insurance companies and
payers on the price of the therapy. Thus,
QALY not only helps in deciding the price
of anti-cancer medications, but also, proves
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Vol.5; Issue: 11; November 2018
the value proposition which further helps in
the value-based and outcome based pricing
of biosimilars and biologics launched in
India. The amount of life added to the
patient along with the quality of the life can
be useful dimensions for marketing of
biologics and biosimilars.
QALY for biologics and biosimilars in
Diabetes
In India, diabetes has considered as a
major health care problem with an estimated
66.8 million people suffering from the
condition, representing the largest number
of any country in the world. The healthcare
sector and economy in India has greatly
affected by the rising burden of diabetes.
The goal of healthcare experts in India is to
transform India into a diabetes care capital
in the world. In 2000, India topped the
world with 31.7million people with diabetes
mellitus followed by China and United
States in second and third place
respectively. According to the study done
by Wild et. al., the maximum increase in the
prevalence of diabetes mellitus India is
predicted with a huge increase globally from
171 million in 2000 to 366 million in 2030.
[8]
India currently faces an uncertainty
about future in relation to the potential
burden that diabetes may impose on the
country. To make evidence-based health
decisions, it is very important to conduct
studies focusing on economic evaluations.
Consequently, also offer the best risk and
cost-effective treatment choice along with
better quality of life for diabetic patients. [9]
The use of one or other value-based
tools in a particular situation is decided by
the attributes of the different methods.
Quality- adjusted life years (QALY) are
health outcome measures that are attained
when utility scores are combined with
survival times. Health utility scores may
vary by geographic conditions and can be
affected by variables like prevalent cultural
norms. In type 2 diabetes, weight loss is an
important therapeutic intervention. In the
case of diabetes, QALY is derived from
such utilities and these are important in
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 Manish Adhia et.al. Quality Added Life Years: A Tool for Biologics and Biosimilars Marketing
terms of decisions regarding reimbursement
policies, insurance policies and cost-
effectiveness. [10]
Non-parametric boots trapping
strategy was used in stimulation to construct
confident intervals around the data. The
incremental cost effectiveness ratio (ICER)
per quality adjusted life year (QALY) was
calculated in the respective currency and as
a fraction of the gross domestic product
(GDP) per capita for each country. ICER
reveal the cost per unit of benefit from
changing from one treatment to another
treatment depending on various aspects.
Cost effectiveness of the treatment is
already setup as per the requirement by
WHO Choosing Interventions that are cost
effective (CHOICE) programme threshold
based on GDP per capita. [11] A health
technology is defined as cost effective if
incremental cost per incremental QALY
gained falls between the range of 1.0- and
3.0-times GDP per capita, highly cost
effective if incremental QALY gains are
less than 1.0 GDP per capita and dominant
(cost saving) if cost per QALY gained are
less than 0.00 based on the studies
performed by Gupta et al., reduction on 30
years incidence of diabetes related
complications was observed. The relative
risks such as the risk of myocardial
infarction were taken in consideration and
observed a reduction in it by 19%. Whereas
the risk of dialysis was projected to fall by
64% in India. On the basis of all this data
and evidences the estimation for QALY
gained was drawn as 4.75 for India. The
increase in total current costs that would
help in delivering an ICER of 3.0
GDP/QALY was estimated to be 252% for
India. [12]
In the study conducted by Berhanu
et al, the main objective was to evaluate the
costs associated with the use of long-acting
insulin analogues (LAIAs) compared with
non-LAIA agents, including human insulin,
oral antidiabetic drugs, and other injectable
therapies, in the treatment of patients with
type 1 diabetes (T1D) or type 2 diabetes
(T2D). they identified patients using LAIAs
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Vol.5; Issue: 11; November 2018
had higher drug costs than those using
OADs and NPH but had neutral or reduced
total and diabetes-related costs compared
with patients using non-LAIAs. Use of
LAIA pen-delivery systems may lead to
improved adherence and reduction in costs.
Patients receiving insulin glargine
demonstrated higher adherence and
persistence than patients on insulin detemir.
Insulin Glargine found to be dominant to
$26,179/QALY than its competitor. On the
other hand insulin detemir was found to be
dominant to $3951/QALY than its
competitor i.e.insuline glargine only.
Glargine consistently less costly (annual
savings per patient of $195-$778; >$70
million 10-year total cost savings. Also
when detemer treatment is compared with
NOH treatment. Economic models suggest
that LAIAs are more cost-effective than
NPH for T1D; for T2D, insulin glargine is
more costly than NPH but less so than
insulin detemir. [13]
Diabetes is considered as chronic
disease due to major complications
associated with it such as renal dysfunction,
neuropathy, retinopathy, lever dysfunction,
diabetic foot, etc. due to all these
complications associated with diabetes, the
treatment of diabetes become costlier in
total. These costs are not only financial but
also affecting directly or indirectly, to the
individual or to the whole family of the
individual. Studies done till the date in India
shows that the economic burden of diabetes
care on families of the diabetic patients is
raising rapidly. 85-95% of the total
treatment cost should paid by individuals
suffering from diabetes and their family
from household income. Taking into
consideration that people diagnosed with
diabetes can have significantly higher
healthcare requirements and expenditures
than in the absence of diabetes, the growing
prevalence of diabetes will tremendous
future challenges for low to middle income
countries. In this context, an intervention
that can deliver increased life expectancy of
more than 1 year with reduced incidence of
diabetes related complications and delayed
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 Manish Adhia et.al. Quality Added Life Years: A Tool for Biologics and Biosimilars Marketing
onset of these would appear attractive to
patients as well as practitioners. [14]
QALY for biologics and biosimilars in
rheumatoid arthritis
Despite advances in treatment, RA
remains a remarkably complex disease to
diagnose and manage. There are multiple
phenotypic and genotypic variations in the
pathogenesis of the disease that affect both
the course of RA and the outcome of
therapy. Some patients may have milder
disease that never progresses to significant
joint damage or functional impairment
regardless of treatment received, while
others experience a highly aggressive course
that may require multiple attempts at
treatment before the disease is brought
under control. Similarly, both initial
response to a given treatment and the
durability of that response may vary even
within phenotypically-similar populations;
some individuals may have initial response
with a short-lived remission, others may
have a more robust initial and subsequent
response, and still others may have
inadequate response to many Targeted
Immunomodulators before finding an
appropriate treatment. In addition to
concerns regarding costs associated with
dose increases, TIMs have also received
considerable attention for rising prices in
recent years. The MRP for the two TIMs
with the leading market share in RA,
adalimumab and etanercept, have risen 70-
80% in the last three years. [15] These prices
do not consider discounts, rebates, or
payment assistance programs provided by
manufacturers. However, even after
discounts and rebates, TIM costs remain
substantial. The institute for clinical and
economic review, New England developed a
model to determine the long-term cost
effectiveness of TIMs used in rheumatoid
arthritis with the primary outcomes being
discounted lifetime total payer costs, life
years, quality adjusted life years (QALY)
and incremental cost effectiveness ratio.
The base case results reflected that
the treatment with TIMs significantly
increased the QALY over the lifetime
International Journal of Research & Review (www.ijrrjournal.com)
Vol.5; Issue: 11; November 2018
horizon. Using this base case model, they
could successfully apply a value-based
pricing for their two investigational drugs as
compared to their other counterparts.
A significant study undertaken by
Bin Wu et al used QALY to understand the
incremental costs and additional quality of
life added of the 7 competing therapies used
for the treatment of rheumatoid arthritis.
When comparing the cost of therapy of
tDMARDS vs the biologicals, it was
observed that the drug costs contributed to
just 40% of the overall cost of treatment
while in biologicals they contributed to 90%
of the associated costs. The cost-effective
frontier that they developed showed the
most efficient strategy to be that with
infliximab with an ICER of $26562.4
followed by infliximab + rituximab,
adalimumab + rituximab and etanercept +
rituximab with ICER of $32034.3,
$121,344.4 and $581,525.9. Though the
costs associated with the biologicals and
biosimilars are higher as compared to the
costs associated with the traditional
DMARD therapy, the incremental life years
added and quality of the life was much
higher than that of the traditional therapies.
[16]
Given the multiple options available
for the management of rheumatoid arthritis,
QALY can help in driving the physician’s
decision towards a suitable therapy (class
choice and brand choice). Another factor
which is very significant in justifying the
use of QALY is the genetic predisposition
of the individual which gives a better
QALY with one therapy over the other. [17]
Conclusion- a 360-degree view of QALY
for marketers
Cancer, diabetes and rheumatoid
arthritis are lifetime conditions which has
immense psychological trauma not just for
the patient but also for the caregivers and
family members. The above examples of
QALY in three major diseases converge
towards the ability of QALY in establishing
the value of a therapy which ultimately
helps in outcome-based models of pricing.
[18]
A lot of factors account a Healthcare
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 Manish Adhia et.al. Quality Added Life Years: A Tool for Biologics and Biosimilars Marketing
professional’s decision of prescribing a
particular biologic or biosimilar, of which
cost continues to be major concern. A value-
based pricing approach for such molecules
appears to be a silver lining for pharma
players. Selling of expensive biologics and
biosimilars involves a lot of stakes
especially since the costs associated with the
manufacture and development of such
molecules continues to be high. QALY as a
metric can be subsequently utilised for
pitching the value proposition of biosimilars
and establishing the cost effectiveness of
biologics and biosimilars.
The primitive use of QALY in
understanding the cost effectiveness of
therapy has already been understood. What
additionally can be leveraged upon is the
use of this metric in different parts of the
product lifecycle for customised marketing
communication at different touch points
depending on the stakeholders involved.
While in the development and approval
phase QALY can be used for establishing
the efficacy of the therapy, in the
commercialization phase, QALY can be
used as a tool by the marketers to
differentiate with the other biosimilars
available and as a tool for negotiation with
the insurance companies in order to obtain
an insurance coverage especially for the
innovator biologics.
An important aspect of acceptance
of a biosimilar amongst the physician’s
include establishing the similarity of the
biosimilar with respect to the reference
biologic available. Amongst the different
components of the totality of evidence,
QALY can also be incorporated eventually.
One of the prime factors in driving a
prescription is the value that the physician
sees in the molecule/therapy. Providing
physicians with economic data helps in
making them understand how the care
provided by one company differs from the
other. In conclusion, when combined with
other marketing tools of patient support and
patient assistance programs, QALY can help
in establishing the value proposition of
biologics and biosimilars. Wherever there
International Journal of Research & Review (www.ijrrjournal.com)
Vol.5; Issue: 11; November 2018
are options available to reach the same
therapeutic objective, QALY stands out as a
science-based point-of-differentiation which
can help drive physician’s prescription.
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How to cite this article: Adhia M, Bhasin B, Sakhrale S. Quality added life years: a tool for
biologics and biosimilars marketing. International Journal of Research and Review. 2018;
5(11):212-219.

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